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Completed

NCT Number: NCT01768429

The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 40-70 years
  • BMI 25-32 kg/m2
  • fasting plasma glucose 5.6-7.0 mmol/l
  • 2 h plasma glucose in oral glucose tolerance test <=11 mmol/l
  • fasting serum total cholesterol <=7 mmol/l
  • fasting serum LDL cholesterol <=5 mmol/l
  • fasting serum triglycerides <=4 mmol/l

Exclusion criteria

  • any chronic disease or condition that hamper the ability to follow dietary intervention
  • chronic liver, thyroid or kidney disease
  • alcohol abuse
  • diabetes
  • recent weight loss
  • recent myocardial infarction
  • corticosteroid therapy
  • psychiatric disorders which need drug treatment
  • cancer under treatment
  • fish allergy or other extensive food allergies
  • exceptional diets (like Atkin's or vegan diet)

Treatment and study plan

Fatty fish

Behavioral

Lean Fish

Behavioral

Alpha-linolenic acid

Behavioral

Control

Behavioral

Primary outcomes

  1. Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test

    Time frame: Baseline and 12 weeks

    change in glucose metabolism

  2. Serum lipid profile

    Time frame: Baseline and at 12 weeks

    Change in serum lipid profile

  3. Blood pressure

    Time frame: Baseline and 12 weeks

    Change in blood pressure

  4. Serum inflammatory markers

    Time frame: baseline and 12 weeks

    Change in serum inflammatory markers

  5. Plasma and adipose tissue lipidomic profile

    Time frame: Baseline and 12 weeks

    Change in plasma and adipose tissue lipidomic profile

  6. Plasma and urine metabonomics

    Time frame: Baseline and 12 weeks

    Change in plasma and urine metabonomics

  7. Gene expression in adipose tissue and peripheral blood mononuclear cells

    Time frame: Baseline and 12 weeks

    Change in gene expression in adipose tissue and peripheral blood mononuclear cells

Secondary outcomes

  1. Reverse cholesterol transport

    Time frame: Baseline and 12 weeks

    Change in reverse cholesterol transport

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Kuopio University Hospital
  • VTT Technical Research Centre, Finland

Registry information

Important dates

Study start
2012
Primary completion
2014
First posted
Jan 15, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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